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Expired calibration of infusion/drivers

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Guest user Created:   Oct 30, 2019 Last commented:   Oct 30, 2019

Expired calibration of infusion/drivers

I'm looking for information on expired calibration of infusion/drivers. If an infusion/driver had a service/calibration sticker stating should not be used after April 2019 and was being used in an intensive care unit to keep a person alive would this breach the regs or SOP

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ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Oct 30, 2019

Yes, it is a violation of both the regulations and the SOP. 

For more information about calibration, please read this article:

Calibration requirements in ISO 13485“ https://advisera.com/13485academy/blog/2019/03/08/calibration-requirements-in-iso-13485/

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Oct 30, 2019

Oct 30, 2019

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